Biogen · 1 day ago
Senior Director, Global Regulatory CMC- Drug- Device Combination Products
Cambridge, MA
Full-time
Hybrid
Director/Executive
$241K/yr - $332K/yr
15+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. The Senior Director, Global Regulatory CMC will lead the regulatory strategy for drug-device combination products, ensuring compliance and influencing global regulatory policy throughout the product lifecycle.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Define and own the global regulatory CMC strategy for drug-device combination products, diagnostics, and medical devices
Serve as the primary regulatory authority for complex, high-risk programs for all non-implantable device programs
Lead global regulatory strategy development and execution across development, registration, commercialization, and lifecycle management
Ensure quality, consistency, and timeliness of global CMC regulatory submissions across all regions
Act as the senior regulatory representative with global Health Authorities for device and combination product portfolios
Mentor and develop senior leaders and regulatory experts, fostering a culture of accountability and strategic thinking
Provide executive regulatory leadership for quality systems oversight, including change control and deviation management
Standardize processes and embed best practices to improve efficiency and scalability
Represent Biogen in external industry forums and influence regulatory standards and paradigms
Qualification
Required
Bachelor's degree and 15+ years of industry experience in Medical Device and Combination Product Regulatory Affairs with at least 10 years of experience leading global regulatory organizations within pharmaceutical or biotechnology environments
Demonstrated regulatory leadership across Class II devices, In-Vitro Diagnostics, and Digital Health Solutions
Extensive experience leading global Health Authority engagements and negotiations
Proven ability to influence enterprise strategy, governance, and industry standards
Strong track record of building, scaling, and sustaining high-performing global teams
Expert knowledge of evolving regulatory expectations for device and combination product licensure
Preferred
Advanced degree in life sciences, engineering, biotechnology, law, or pharmaceutical sciences
Experience with lifecycle management strategies and differentiated drug-device combination products
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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